Standards
EDQM (European Directorate for the Quality of Medicines & HealthCare)
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Council of Europe directorate, based on the Convention on the Elaboration of a European Pharmacopoeia, that compiles and publishes the European Pharmacopoeia (Ph. Eur.), whose standards are legally binding in the signatory states of the Convention.
The EDQM gives its mission as contributing to public health protection, with long-standing expertise in ensuring the quality of medicines by developing international quality standards; its portfolio now also covers pharmaceutical care, substances of human origin and consumer health. It provides a common, harmonised, legal and scientific framework of standards for medicines and health products, and co-ordinates co-operation activities to help stakeholders implement them.
Each edition of the Ph. Eur. comprises three issues published online over a 12-month period, each with new and revised texts adopted at one of the three annual sessions of the European Pharmacopoeia Commission. Ph. Eur. monographs for medical gases include 0417 Oxygen (cryogenic distillation, minimum 99.5%, as the EDQM described it in April 2020), 2455 Oxygen (93 per cent) from single-stage adsorption plants, 3098 Oxygen (98 per cent), 1238 Air, medicinal and 1684 Air, synthetic medicinal; the EDQM Knowledge database lists them as in use.
Sources
- EDQM, European Pharmacopoeia: all you need to know
- EDQM, Vision, mission and values
- EDQM, The European Pharmacopoeia and certificates of suitability (presentation published by the EMA), PDF p. 2
- EDQM Knowledge database, Ph. Eur. monographs 0417, 2455, 3098, 1238 and 1684
- EDQM news, Oxygen (98 per cent) consultation: monographs 0417 and 2455 (16 April 2020)
- EDQM, Ph. Eur. monograph histories 2455 and 3098
Ultra Controlo figures come from its technical datasheets. Third-party facts were read at the source on the date shown.